Study on Margetuximab or Trastuzumab for Stage II-III HER2-Positive Breast Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT04425018
This clinical trial is exploring how well two different drug combinations work in treating stage II-III HER2-positive breast cancer before surgery. The study compares the effects of using either Margetuximab or Trastuzumab with other chemotherapy drugs.
Patient Parameters
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Program Overview
The aim of this study is to see how effective two different combinations of drugs are in treating stage II-III HER2-positive breast cancer before surgery. Participants will receive one of the following drug combinations: Paclitaxel, Pertzumab, and Margetuximab (Margenza) or Paclitaxel, Pertzumab, and Trastuzumab (Herceptin).
Description
This study is a Phase II trial where participants with stage II-III HER2-positive breast cancer will be randomly assigned to one of two treatment groups. One group will receive Paclitaxel, Pertzumab, and Margetuximab, while the other group will receive Paclitaxel, Pertzumab, and Trastuzumab. The treatment will last for 12 weeks before surgery, and participants will be monitored for 10 years after surgery. Some participants may continue receiving Margetuximab for a year if they respond well to the initial treatment.
The study involves screening for eligibility, receiving the study treatment, and undergoing laboratory tests and biopsies. About 171 people are expected to participate. This trial is testing the safety and effectiveness of these drug combinations to see if they work well in treating this type of breast cancer. The FDA has approved the use of Paclitaxel, Trastuzumab, and Pertzumab for pre-operative treatment of stage II-III HER2-positive breast cancer, and Margetuximab is approved for advanced HER2-positive breast cancer.
Eligibility Criteria
Inclusion Criteria
- Have stage II or III HER2-positive breast cancer with a tumor size of at least 1.5 cm.
- Have a specific genetic marker (low affinity CD16 germline genotype).
- Be HER2-positive according to specific medical criteria.
- Have hormone receptor status determined (ER/PR).
- Can have cancer in both breasts if both are HER2-positive.
- Be 18 years or older.
- Have good overall health with a performance status of 0 or 1.
- Have adequate organ function based on specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
- Be willing to sign informed consent and undergo research biopsies.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Have an active infection requiring treatment.
- Have uncontrolled high blood pressure or significant heart disease.
- Have severe symptoms from nerve damage.
- Have other serious health conditions that could interfere with treatment.
- Have received any prior treatment for the current breast cancer.
- Have had invasive breast cancer within the past 5 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Georgetown University Medical Center | 20007 | Washington D.C. | District of Columbia |
| MedStar Washington Hospital Center | 20010 | Washington D.C. | District of Columbia |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Dana-Farber Brigham Cancer Center - Foxborough | 02035 | Foxborough | Massachusetts |
| Dana-Farber at Milford | 01757 | Milford | Massachusetts |
| Dana-Farber at South Shore Hospital | 02190 | Weymouth | Massachusetts |
| Montefiore Medical Center | 10461 | The Bronx | New York |
| UPMC Hillman Cancer Center - Arnold Palmer at Mountain View | 15601 | Greensburg | Pennsylvania |
| UPMC Hillman Cancer Center - Arnold Palmer at Norwin | 15642 | Irwin | Pennsylvania |
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